Immediate Postmastectomy Breast Reconstruction (Strattice Breast)

NCT00619762 | Completed Results

• 1 other identifier: LFC2007.01.01
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 5

Brief Summary

This prospective, multicenter, open-label study will assess the clinical outcomes of the LTM product in three planned analyses. The primary objective of this study is to prospectively assess the clinical outcomes associated with the use of LTM in two-stage (expander then permanent implant) immediate post-mastectomy breast reconstruction.

Conditions

Breast Cancer

Keywords

Breast reconstruction

Outcome Measures

Primary Outcomes (1)

• Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix

  Evaluation of 3 histology parameters, fibroblast infiltration, immune cell response \& revascularization, expressed as frequency distributions. Samples evaluated for presence of fibroblasts (cellularity), neovascularization \& immune cell response using 4 pt scale. Fibroblast Infiltration: 1=None,2=Few,sparse,3=Moderate,4=Dense. Revascularization:1=None,2=Few randomly dispersed capillaries,3=Moderate; mostly homogenous distribution of new vessels,4=Significant,uniformly distributed vessels; both capillaries and arterioles. Immune Cell response: 1= None,2=Few,normal healing response,3=Moderate,4=Significant;above expected presence for healing. 4 high power(HP)fields reviewed \& if uniform in appearance/cellular distribution, 4 considered representative of sample as a whole. If non-uniform distribution observed, 3 HP fields of "sparse or light" distribution \& 3 HP fields of dense distribution counted \& results averaged. Tissue sample then assessed for overall acellularity \& expressed as %.

  At the time of expander/implant exchange (Stage II),

Secondary Outcomes (1)

• Severity of Local Inflammation at and Around the Surgical Site

  Postoperative Day 7, 14, 21, 30 days

Interventions

LTM - a porcine-based surgical mesh DEVICE

Use of LTM to support weak and/or absent soft tissue to facilitate immediate breast reconstruction postmastectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

women undergoing two-stage immediate breast reconstruction following a skin sparing mastectomy will be recruited from up to ten (10) participating centers

You may qualify if:

• A candidate for immediate, two-stage breast reconstruction using LTM following a skin sparing mastectomy
• An ASA Physical Status Classification5 of 1 or 2 (see App I)
• Estimated life expectancy \> 1 year

You may not qualify if:

• Clinically significant systemic disease
• Received inductive chemo-therapy within 2 months prior to mastectomy or radiation therapy to the region at any time
• Predicted excised breast mass of \>750 gms
• Co-morbid factors which predispose to postoperative infection, such as insulin dependent diabetes, smoking, chronic steroid use, malnourishment, or co-existent infection
• Need for tissue flap in addition to expander
• History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction
• Enrollment or plans to enroll in another clinical trial during this study that would affect the patient's safety or results of this trial
• Any of the conditions identified within the labeled contraindications, i.e. sensitivity to porcine derived products or polysorbate

Sponsors & Collaborators

• LifeCell: lead

Study Sites (5)

Unknown Facility

Washington D.C., District of Columbia, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Great Neck, New York, United States

Location

Unknown Facility

Willow Grove, Pennsylvania, United States

Location

Unknown Facility

McLean, Virginia, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue sample

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Small number of subjects and breasts analyzed.

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: LifeCell

djacobs@lifecell.com

908.809.7856

Study Officials

• Michael Franz, MD

  LifeCell

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: February 21, 2008
• Study Start: October 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 8, 2016
• Results First Posted: May 15, 2013

Record last verified: 2016-10

Locations

US (5)